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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-2567 | Other Grant/Funding Number | Stig & Ragna Gorthons Foundation | |
| ALF Region Skåne | Other Grant/Funding Number | Governmental funding of clinical research within the National Health Services |
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| Name | Class |
|---|---|
| Skane University Hospital | OTHER |
| Lund University | OTHER |
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The study aims to assess the existence of intraluminal malignant cells and the appropriate fluid volume needed to perform rectal washout during transanal total mesorectal excision (taTME) for rectal cancer.
Twenty patients undergoing taTME for rectal cancer is included. Following the closure of the rectal lumen by a purse string suture, rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity. Each sample is cytologically examined by a pathologist and labelled either malignant or non-malignant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing rectal washout in transanal mesorectal excision | Patients undergoing rectal washout in transanal mesorectal excision for rectal cancer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectal washout | Procedure | Rectal washout is performed intraoperatively before transection and means irrigation of the rectum following the closure of the rectal lumen below the tumour with a purse string suture. Rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity. |
| Measure | Description | Time Frame |
|---|---|---|
| Existence of intraluminal malignant cells in fluid samples from rectal washout | Positive/negative cytology | Intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Fluid volume needed to perform rectal washout during transanal total mesorectal excision to eliminate intraluminal malignant cells | Positive/negative cytology | Intraoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing transanal mesorectal excision at Slagelse Hospital, Denmark
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Buchwald | Skåne University Hospital, Malmö, Region Skåne, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Slagelse Hospital | Slagelse | Region Sjælland | 4200 | Denmark |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |